| Catalog Number |
650705550001 |
| Medical Device Problem Code |
Patient Device Interaction Problem (4001)
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| Health Effect - Clinical Codes |
Pain (1994); Discomfort (2330); Insufficient Information (4580)
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Type of Reportable Event
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Malfunction
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Event or Problem Description
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between (b)(6) 2025.This report summarizes 1 malfunction event(s), where it was reported the device experienced pinch/crush point.There was 1 event with patient involvement; it is unknown at this time what the patient experienced.
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Additional Manufacturer Narrative
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This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device is pending evaluation.Evaluation results findings (components/results).1 device: insufficient information / results pending completion of investigation.There was no remedial action taken.This device is not labeled for single use.
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Event or Problem Description
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No new information.
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Additional Manufacturer Narrative
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The device that was pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Evaluation results findings (components/results).1 device: controller/dust or dirt problem identified.
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Search Alerts/Recalls
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